The U.S. Food and Drug Administration announced on May 6, 2025, its intention to expand the use of unannounced inspections of foreign manufacturing facilities that produce foods, essential drugs, and other medical products intended for American consumers and patients.The change builds on the Office of Inspection and Investigations' pilot program of unannounced foreign inspections in India and China and is intended to ensure that foreign companies receive the same level of regulatory scrutiny and oversight as domestic companies, the agency said in a statement.
“For too long, foreign companies have benefited from a double standard: advance notice before plant inspections, while American manufacturers are held to rigorous standards with no advance notice at all.
“This obligation ends today. This is a critical step for FDA as part of a broader strategy to get foreign inspections back on track,” said FDA Commissioner Martin A. Makary .
Additionally, FDA will evaluate the agency's policies and practices to improve the foreign inspection program and ensure FDA is the central point of reference for regulatory oversight.
These changes will include clarifying policies that will allow FDA researchers to refuse travel accommodations from regulated companies, including lodging and transportation services (taxis, limousines, and rental vehicles), to ensure the integrity of the oversight process.
In a statement, FDA said it conducts approximately 12,000 domestic inspections and 3,000 foreign inspections each year in more than 90 countries.
While U.S. manufacturers are frequently subjected to surprise inspections, foreign companies often have weeks to prepare, compromising the integrity of the oversight process.
Despite advance warning from foreign companies, the FDA still found serious deficiencies more than twice as often as domestic inspections.
Only in specific cases and programs are FDA national inspections announced in advance to ensure that adequate documentation and personnel are available during the inspection.
However, regulated firms do not have the authority to negotiate the day or time of the inspection, nor should foreign firms have the ability to do so.
The FDA is authorized to take regulatory action against any company that attempts to delay, deny, or limit an inspection , or that refuses to allow entry for a surprise inspection of drugs or devices. (Source: https://www.quotidianosanita.it/ )